E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with moderate LUTS (Lower Urinary Tract Symptoms) associated with benign prostatic hyperplasia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004446 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
I-PSS improvement (I-PSS12months – I-PSSbaseline adjusted for I-PSSbaseline by means of analysis of covariance)
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E.2.2 | Secondary objectives of the trial |
•Response rate; Responder definition: improvement of at least 25% in I-PSS •I-PSS Subscale Nocturia •I-PSS treatment difference after 6 months, evaluated by means of analysis of covariance with I-PSSbaseline as covariate and repeated measurements of I-PSS after 1, 2, 4, 6, 8, 10, and 12 months. •Quality of life: a) SF-36 Total score and QoL-Subscale I-PSS (Bother Score) b) sexual dysfunction: PAS SFI (Short Form) •Uroflow: a) Maximum flow-rate Qmax b) Average flow Qave c) Miction time •Post-void residual urine volume •Prostatic volume assessed by DRE Safety parameters: •Adverse events •Safety laboratory •Vital parameters
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Male out-patients aged 40 to 80 •Patients with LUTS (lower urinary tract symptoms) associated with BPH experiencing an I-PSS 13 and ≤ 19 •Prostate Volume ≤ 40 ml •Residual Volume ≤ 150 ml •Willingness to pass all necessary examinations over the entire time span of 48 weeks treatment
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E.4 | Principal exclusion criteria |
•I-PSS < 13 and > 19 •Prostate Volume > 40 ml •Residual Volume > 150 ml •Prostate cancer and transitional cell cancer of the lower and upper urogenital tract •Status after radical pelvic or urogenital surgery •Previous surgical or laser treatment of BPH •PSA level > 4.0ng/ml •Voiding volume for uroflow measurements ≤ 150 ml •Acute or chronic infection of the urinary tract •Acute or chronic infection of the prostate •Bladder stones •Bladder shrinkage •Permanent catheterization •Acute or chronic urinary retention •Incontinence •Urethral stricture •Treatment with an alpha-blocker within the last 8 weeks •Treatment with an 5-alpha-reductase-inhibitor within the last 6 months •Disallowed concomitant treatment (cf. chapter 6.3) •Impairment of bladder function due to diabetes mellitus and/or CNS diseases (e.g. multiple sclerosis) •Other malignancies with chemotherapy or radiotherapy within the last 12 months •Life expectancy less than 3 years •Advanced renal insufficiency (creatinine > 2,2 mg/100ml) •Advanced hepatic insufficiency (SGOT/ASAT;SGPT/ALAT > 2,5 x upper normal value)
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E.5 End points |
E.5.1 | Primary end point(s) |
I-PSS improvement (I-PSS12months – I-PSSbaseline adjusted for I-PSSbaseline by means of analysis of covariance) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |